Sponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law

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1 EU Directives Pharmacovigilance Legislation, SOPs and Reporting Louise Boldy, Governance & Safety Manager David Martin, Pharmacovigilance Monitor EU Legislation 2001/20/EC 2005/28/EC EudraLex Vol 10 UK Law Statutory Instruments 2004/1013 (primary legislation) 2006/1938 (amendments) 2006/2984; 2008/0941; 2008/3097 SOP 11 Identifying, recording and reporting AEs for CTIMPS SOP 15 Preparing and submitting progress & safety reports Roles and Responsibilities Sponsor Regulatory Agency MHRA Investigator Sponsor Responsibilities Accountable for overall conduct of the trial Responsible for ongoing safety evaluation of the IMP. Protect the safety of current and future patients involved in a study. Develop & establish overall safety profile of IMP. Is expected to undertake their own assessment of SAEs and decide if they are SARs or SUSARs

2 Sponsor Requirements Report UK SUSARs to MHRA and main REC within defined timelines Fatal/life-threatening within 7 days Non-fatal/life-threatening within 15 days SUSARs now reported electronically Annual Safety Reporting Investigator Responsibilities Must record all AEs during a study records can be inspected by the Sponsor decide if an event is serious decide if an event is a reaction decide if a reaction caused by IMP Must immediately notify the Sponsor of SAE/Rs (usually within 24 hrs). Investigator Responsibilities Trial design Patient recruitment and safety IMP accountability Accuracy of results Analysis and interpretation End of Trial Declaration (MHRA, Ethics) End of Trial Report SOP 11 IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CTIMPS What is an Adverse Event? any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment Directive 2001/20 EC What information is needed to report an event? Sufficient information to identify: The clinical trial The trial subject The event The IMP The reporter

3 Is it serious? results in death is life-threatening required inpatient hospitalization or prolongation of existing hospitalisation results in persistent or significant disability or incapacity is a congenital anomaly or birth defect is otherwise considered serious (ICH Guidelines for GCP) If the Adverse Event is Serious The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or Investigator s Brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed written reports. Directive 2001/20 EC - Article 16 Recording and Reporting All Adverse Events must be recorded Case Report Form (CRF) Adverse Event Log Serious Adverse Events must be reported to the sponsor Is it a Reaction? Marketed medicinal products: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. (ICH Guidelines for GCP) Is it expected? Clarify what section(s) of the IB/SPC are being used to assess expectedness. Any person making expectedness assessments must understand the regulatory definition An adverse reaction the nature or severity of which is not consistent with the applicable product information. If multiple people are performing these assessments there must be consistency. What happens to your SAE? Check for completeness and signature Assess for expedited reporting Enter into Pv database Assign WHO-ICD code Confirm receipt and code to investigator, check that code is appropriate Arrange for independent clinical review complete subsequent actions Follow up SAE to resolution if required Expedited reporting to MHRA if required

4 Expedited Reporting Requirements Adverse Reaction Serious Unexpected Suspected = SUSAR If the IMP is suspected of being the cause of a serious adverse reaction it must be reported to the MHRA within Seven days if fatal or life-threatening Fifteen days for other suspected reactions Other Reporting Requirements Question 1 It is the sponsor s responsibility to keep all investigators undertaking clinical trials for which they are also acting as sponsor informed of SUSARs, where such trials also involve the same IMP. Reports sent to the Investigator regarding SUSARs from other trials of the same medicinal product must be reviewed by the Investigator and acted upon if appropriate. Copies of such SUSAR reports must be kept in the ISF and the TMF. If a subject is treated in A&E but not admitted to hospital, is this an SAE? Answer 1 Probably not, but Is it covered in the protocol? What did the subject attend A&E for? Could it be otherwise considered serious? If the decision is not to report the event as serious, it must be entered in to the AE log Question 2 If a subject is admitted to hospital for a pre-planned operation, is this a SAE?

5 Answer 2 Probably not but This should be covered in the protocol. If elective surgery is excluded in the protocol an event may still be reportable if: Complications arise which cause prolongation of hospital stay The IMP is possibly linked to any drug interactions during the hospital stay Question 3 A well known side-effect of product X is hypotension. A trial subject is hospitalised due to hypotension after receiving the product. Does this still need to be reported to the Sponsor as a SAE? Answer 3 Yes unless excluded by the protocol Even if excluded did the reaction occur with greater than expected severity, or rapidity of onset? SOP 15 PREPARING AND SUBMITTING PROGRESS AND SAFETY REPORTS Reporting Annual Safety Reports becoming Development Safety Update Reports Annual Progress Reports Pregnancy Reporting Expedited Reporting Urgent Safety Measures Other Reporting Requirements Annual Safety Reports (CTIMPs) Annually from date of CTA approval Prepared by TASC on behalf of the Chief Investigator Prepare ASR Line listing of SARs Send to CI for checking and IMP safety assessment. Submit to MHRA Submit to REC

6 Development Safety Update Reports DSURs Annually, on the International Birth Date of the IMP Includes all trials which use same IMP Annual Progress Reports Annually from date of REC approval NRES annual progress report form (CTIMPs or non CTIMPs form) First annual progress report should state the commencement date for the study or an explanation for the delay. Pregnancy Reporting Not considered an AE or SAE Unless a congenital abnormality or birth defect Should be notified on pregnancy reporting forms (TASC website) Pregnancies of a trial participant or the female partner of a trial participant should be followed up to outcome For female partners of male trial participants, consent is required Expedited Reporting The following safety issues should also be reported by the Investigator to the Sponsor in an expedited fashion: An increase in the rate of occurrence or a qualitative change of expected SAR, which is judged to be clinically important. Post-study SUSARs that occur after the trial participant has completed a clinical trial and are notified to the Investigator. New events related to the trial or the development of the investigational medicinal products and are likely to affect the safety of the participants. Recommendations of the Data Monitoring Committee where relevant for the safety of trial participants. The Sponsor is responsible for informing the MHRA and the REC of these safety issues. Urgent Safety Measures CI or PI at participating site may take appropriate safety measures to protect the participants of a CTIMP against any immediate hazard to their health or safety Urgent safety measures can be implemented immediately Investigator should contact Clinical Trial Unit at MHRA and discuss with a medical assessor. Sponsor and REC should also be contacted at this time Investigator must notify MHRA, REC and sponsor in writing within 3 days Where to find the forms TASC Website Please use live forms as they may change Adverse Event Log SAE form, and guidance Pregnancy Notification Form Pregnancy Follow Up Form

7 Contact details Pharmacovigilance Department TASC R&D Office Ninewells Hospital and Medical School Residency Block, Level 3 Dundee DD1 9SY Fax: Telephone Direct: (40296 internal) Admin: (32236 internal)

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